卡式炉-库仑法卡尔费休水分仪联用测定甲型肝炎减毒活疫苗中水分  

Determination of water content in live-attenuated vaccines of hepatitis A using a combination of cassette furnace and Coulometric Karl Fischer titrator

作　　者：杨欢 吴凡 非成瑞 王思捷 申雪 杨力 徐宏山[2] YANG Huan;WU Fan;FEI Chengrui;WANG Sijie;SHEN Xue;YANG Li;XU Hongshan(The Institute of Biological Products Inspection of Yunnan Food and Drug Administration and Inspection,Yunnan,Kunming 650106,China;Laboratory of Arbovirus Vaccine,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]云南省食品药品监督检验研究院生物制品检定所,云南昆明650106 [2]中国食品药品检定研究院虫媒病毒疫苗室,北京102629 [3]工业和信息化部产业技术基础公共服务平台,云南昆明650106

出　　处：《中国医药科学》2024年第23期155-159,共5页China Medicine And Pharmacy

基　　金：云南省科技厅重大科技专项计划(202002AA100008)。

摘　　要：目的建立一种能够快速、高效、准确检测冻干甲型肝炎减毒活疫苗中水分的分析方法。方法探索水分测定法加热程序,建立卡式炉-库仑法卡尔费休水分仪联用法测定冻干甲型肝炎减毒活疫苗的水分,并从专属性、准确度、精密度、耐用性等方面对所建立方法进行方法学验证。结果以加热温度为140℃,加热时间为10 min作为试验条件,进行方法学验证,试验结果显示,专属性符合要求,准确度检测标准品回收率均在99%~101%之间,重复性检测结果相对标准偏差(RSD)在0.76%~0.83%之间,3名试验人员不同时间的检测结果RSD为0.77%。经更换电极、挑战温度波动以及最长放置时间,标准品检测结果回收率均在98%~103%之间,各项检测结果均符合规定。结论本研究所建立的卡式炉-库仑法卡尔费休水分仪联用法,用于测定冻干甲型肝炎减毒活疫苗中水分含量的结果重复性好,操作简单方便。该方法可用于冻干甲型肝炎减毒活疫苗中水分含量的测定。Objective To establish a rapid,efficient,and accurate analytical method for detecting water content in freeze-dried live-attenuated vaccines of hepatitis A.Methods The heating procedure of water content determination method was explored,and the water content of freeze-dried live-attenuated vaccines of hepatitis A was determined by the established method of cassette furnace combined with Coulometric Karl Fischer titrator.The established method was verified by methodology from the aspects of specificity,accuracy,precision and durability.Results With the heating temperature of 140℃and the heating time of 10 min as the test conditions,the methodology was verified.The test results showed that the specificity met the requirements,the recovery rate of the accuracy test standard was between 99%and 101%,and the relative standard deviation(RSD)was between 0.76%and 0.83%,and the RSD of three testers at different times was 0.77%.After replacing the electrode,challenging the temperature fluctuation and the longest storage time,the recovery rate of the standard sample was in the range of 98%to 103%,and all the test results met the requirements.Conclusion The cassette furnace combined with Coulometric Karl Fischer titrator method established in this paper has good repeatability and simple and convenient operation for determining the water content in freeze-dried live-attenuated vaccines of hepatitis A.This method can be used for the determination of water content in freeze-dried live-attenuated vaccines of hepatitis A.

关 键 词：卡式炉 库仑法卡尔费休 水分 甲型肝炎减毒活疫苗 

分 类 号：R473.71[医药卫生—护理学]